FDA Adverse Event
Injury
Summary report: N
TRITANIUM BPLATE TRIATHLON S5
MDR report key: 8204502
·
Received December 28, 2018
Report
- Report Number
- 0002249697-2018-04180
- Event Type
- Injury
- Date Received
- December 28, 2018
- Date of Event
- December 3, 2018
- Report Date
- December 28, 2018
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- UDI-DI
- 07613327041507
- PMA / PMN Number
- K141056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO MEDIAL TIBIAL COMPRESSION. NO POSSIBLE CAUSES OR CONTRIBUTORS FOR COMPRESSION WERE REPORTED TO THE REP. A TRITANIUM BASEPLATE AND CS INSERT WERE REVISED TO A SIZE 5 UNIVERSAL BASEPLATE WITH 12X100 STEM AND A 5X11 CS INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1041194 | TRITANIUM BPLATE TRIATHLON S5 | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C | MBH | STRYKER ORTHOPAEDICS-MAHWAH | CTD13523 | 07613327041507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R |